Thalidomide fOr the Prevention of Restenosis After Coronary ArtERy Stent Implantation - The TOP RACER Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 主要终点
- Occurrence of binary restenosis 6 months after PCI
研究概览
简要总结
Percutaneous coronary intervention (PCI) with the use of bare metal stents is associated with restenosis in approximately 10% to 50% of cases.
Stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to restenosis and atherosclerosis within the stented segments.
The sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory and antioncogenic properties that could be of benefit in case of PCI with stenting.
详细描述
Percutaneous coronary intervention (PCI) with the use of bare metal stents is associated with restenosis in approximately 10% to 50% of cases.
Stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to restenosis and atherosclerosis within the stented segments.
Indeed, experimental studies indicate a marked activation of inflammatory cells at the site of stent struts, which is likely to play a key role in the process of neointimal proliferation and restenosis. Indeed, tumor necrosis factor and interleukins 1 and 6 are powerful stimuli for smooth muscle cell proliferation.
The sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory and antioncogenic properties that could be of benefit in case of PCI with stenting.
The primary objective of this study is to carry out a double-blind, randomized, placebo-controlled study to assess the effects of oral thalidomide on restenosis rate after successful stent implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A de novo native coronary artery lesions (reference vessel diameter:2.5-3.75 mm)
- •Class I indication to elective percutaneous coronary intervention
- •Stable conditions and no recent acute coronary syndromes
- •Normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-MB, myoglobin, and troponin I)
- •Able to understand and willing to sign the informed CF
- •Contraindications to DES Use (Clinical history difficult to obtain, Expected poor compliance with DAPT, Non-elective surgery required, Increased risk of bleeding
- •Allergy to ASA or clopidogrel/prasugrel/ticagrelor, Indication for long-term anticoagulation, Large Vessels, Focal Lesions)
排除标准
- •Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
- •Indications to DES Use (Small Vessels, Long Lesions Diabetes, In-Stent Restenosis, Complex lesions)
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
Thalidomide
Thalidomide
干预措施: Thalidomide (Drug)
结局指标
主要结局
Occurrence of binary restenosis 6 months after PCI
时间窗: 6 months
6-month angiographic evidence of binary restenosis (defined as an in-stent stenosis _50% at follow-up coronary angiography)
次要结局
- Major adverse cardiac events 6 months after PCI(6 months)
研究者
Francesco Pelliccia
Assistant Professor
University of Roma La Sapienza